(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2010/0168501 A1
`(43) Pub. Date:
`Jul. 1, 2010
`Burnett et al.
`
`US 201001 68501A1
`
`(54)
`
`METHOD AND APPARATUS FOR MAGNETIC
`INDUCTION THERAPY
`
`(76)
`
`Inventors:
`
`Daniel Rogers Burnett, San
`Francisco, CA (US); Christopher
`Hermanson, Santa Cruz, CA (US)
`
`Correspondence Address:
`LEVNE BAGADE HAN LLP
`2400 GENG ROAD, SUTE 120
`PALO ALTO, CA 94.303 (US)
`
`(21)
`
`Appl. No.:
`
`12/508,529
`
`(22)
`
`Filed:
`
`Jul. 23, 2009
`
`(63)
`
`Related U.S. Application Data
`Continuation-in-part of application No. 1 1/866,329,
`filed on Oct. 2, 2007.
`
`(60)
`
`Provisional application No. 60/848,720, filed on Oct.
`2, 2006.
`
`
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6IN 2/02
`(2006.01)
`A61N L/36
`(52) U.S. Cl. .................................. 600/13:607/2; 607/41
`(57)
`ABSTRACT
`An energy emittingapparatus for providing a medical therapy
`includes one or more energy generators, a logic controller
`electrically connected to the one or more energy generators,
`and one or more sensors that are connected to the logic con
`troller for detecting electric conduction in a target nerve. The
`energy generators produce energy focused on the target nerve
`upon receiving a signal from the logic controller, and the
`energy is varied by the logic controller according to an input
`provided by the one or more sensors. The energy emitting
`apparatus includes one or more conductive coils that produce
`a magnetic field focused on the target nerve upon receiving an
`electric current from the logic controller based on input pro
`vided by the sensors. The sensor may also include a micron
`eedle array to detect electrical conduction or an energy emit
`ting apparatus may include a microneedle array to produce or
`deliver energy, e.g., an electrical or magnetic stimulus or
`field.
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`METHOD AND APPARATUS FOR MAGNETC
`INDUCTION THERAPY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`0001. The present application is a continuation-in-part of
`U.S. patent application Ser. No. 1 1/866,329 filed Oct. 2,
`2007, which claims priority to U.S. Provisional Patent Appli
`cation Ser. No. 60/848,720 filed Oct. 2, 2006, each of which
`is incorporated herein by reference in its entirety.
`
`BACKGROUND
`0002. Overactive bladder (“OAB) and urinary inconti
`nence (“UT”) affect over 16% of the American population
`each year, or approximately 34 million men and women.
`Outside of the United States, OAB and UI affects over 46
`million Europeans. The economic cost of OAB and UI is
`estimated to be in excess of S12 billion a year in the United
`States alone.
`0003. Due to the social stigmas attached to OAB and UI
`and to misunderstandings related to the symptoms associated
`with OAB and UI, only 40% of the affected individuals in the
`United States seek medical treatment. Of those 13.6 million
`Americans seeking medical treatment, nearly 30% or 4 mil
`lion individuals are reportedly unsatisfied with their current
`therapy.
`0004 Known treatments for OAB and UI include exercise
`and behavioral modifications, pharmacological therapies,
`Surgical intervention and neuromodulation, but each of these
`treatments exhibits severe limitations.
`0005 Exercise and behavioral modifications often require
`patients to adhere to stringent routines, including scheduled
`Voiding, maintenance of a bladder diary, and intense exercise
`regimens. While this type of treatment may be a viable option
`for a small group of highly dedicated individuals, its daily
`impact on a person’s life makes it unattractive for most
`patients.
`0006 Pharmacological intervention is the most widely
`prescribed therapy for OAB and UI. Unfortunately, patients
`often suffer from side effects related to their drug therapies.
`Such side effects are sometimes serious and are particularly
`pronounced in elderly patient populations that tend to use a
`plurality of medications. In addition, approximately 30% of
`all patients subjected to pharmacological therapies appear to
`be dissatisfied with the efficacy of their prescribed treatments.
`0007 Surgical intervention IS extremely invasive and
`often results in a long-term requirement for catheterization
`that may become permanent in Some instances. The negative
`impact of these procedures on the patient’s quality of life and
`their high expense make Surgical intervention a recom
`mended option only when all other treatment options have
`been exhausted.
`0008 Neuromodulation is another available therapy for
`OAB and UI. In general, pulsed electromagnetic stimulation
`(“PES) has proven to have beneficial effects in a variety of
`medical applications. The related Scientific principle is that an
`electric current passing through a coil generates an electro
`magnetic field, which induces a current within a conductive
`material placed inside the electromagnetic field.
`0009 More particularly, PES has been shown to be an
`effective method of stimulating a nerve positioned within the
`electromagnetic field, thereby affecting a muscle controlled
`by that nerve. For example, in the paper titled “Contactless
`
`Nerve Stimulation and Signal Detection by Inductive Trans
`ducer presented at the 1969 Symposium on Application of
`Magnetism in Bioengineering, Maass et al. disclosed that a
`nerve threading the lumen of a toroid could be stimulated by
`a magnetic field of 0.7 Volt peak amplitude and a 50 us
`duration in a monitor wire, and that such stimulation could
`generate a contraction of major leg muscles in anesthetized
`mammals.
`0010 Various attempts were made in the prior art to use
`PES for treating a variety of ailments. For example, U.S. Pat.
`No. 4.548,208 to Niemi discloses an apparatus for inducing
`bone growth by generating an electric current in the body
`through the external application of an electromagnetic field.
`Such apparatus includes opposing clamps disposed on a limb
`and may optionally include feedback coils and a micropro
`cessor for sensing the magnetic field, so to avoid an overcur
`rent mode. Therefore, this apparatus optimizes the magnetic
`field on the basis of measurements of the generated magnetic
`field.
`0011 U.S. Pat. No. 4,940,453 to Cadwell discloses a
`method and apparatus for magnetically stimulating the neural
`pathways of a higher level organism. In this invention, a
`sinusoidally fluctuating current flow is created through a coil
`that overlies neurons to be stimulated, and frequency of the
`current flow and frequency of the magnetic field produced by
`the coil predetermined to correspond to the time constant of
`the neurons to be stimulated. Sensors for sensing coil condi
`tions, such as coil temperature, may also be included.
`O012 U.S. Pat. No. 5,000, 178 to Griffith discloses an elec
`trical to electromagnetic transducer for applying electromag
`netic energy to damaged parts of a living body by directing
`electromagnetic radiation to a certain damaged body part.
`Electromagnetic radiation is initially generated by a dipole
`consisting of a bar of high permeability material wrapped
`with an electrically conductive coil. Magnetic fields, which
`are generated away from the damaged body part, intersect a
`conductive shield and establish eddy currents, which in turn
`generate magnetic fields opposite and nearly equal to the
`magnetic fields generated by the electromagnetic source. The
`resultant electromagnetic fields reinforce the electromagnetic
`field directed towards the damaged body part and diminish
`the electromagnetic field directed away from the damaged
`body part.
`0013 U.S. Pat. No. 5,014,699 to Pollacket al. discloses a
`non-invasive, portable electromagnetic therapeutic method
`and apparatus for promoting the healing of damaged or dis
`eased living tissue, including fractured bone. These method
`and apparatus involve generating a signal that has a series of
`Substantially symmetric Voltage cycles ofbursted pulses with
`narrow pulse widths of 0.5 to 20 microseconds, and further
`involve converting the signal into an electromagnetic field
`extending into an area that contains tissue to be healed. This
`invention provides for no feedback on the efficiency of the
`applied stimulation.
`0014. In a paper titled “Selective Stimulation and Block
`ing of Sacral Nerves: Research Setup and Preliminary
`Results.” published in Annual International Conference of the
`IEEE Engineering in Medicine and Biology Society, Vol. 13,
`No. 2, 1991, Wijkstrala et al. used an external pulsed magnetic
`coil to stimulate a peripheral nerve for the treatment of uri
`nary incontinence. The authors used a large magnetic field
`produced by a single coil to ensure that the nerve was fired and
`the resulting nerve conduction was frequently painful or
`intolerable. In addition, coil alignment was problematic
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`because an internally implanted coil was utilized, which had
`to be aligned with the fully external magnetic field to stimu
`late the nerve. Due to the difficulty in positioning the device,
`the practical application of this therapy does not permit home
`healthcare usage without a preset alignment and monitoring
`of the nerve, and no provision was made to insure that the
`nerve was actually being stimulated or to adjust the device in
`response to commonly occurring physiologic and anatomic
`variations in nerve locations.
`0015 U.S. Pat. No. 5,181,902 Erickson et al. and U.S. Pat.
`No. 5,314.401 to Tepper disclose pulsed electromagnetic
`field (“PEMF) transducer systems usable to perform PEMF
`therapies (such as after spinal fusion) by generating flux
`aided electromagnetic fields. The drive electronics includes a
`PEMF processor that executes a PEMF program for control
`ling the activation of the electromagnetic fields (field strength
`and cycle).
`0016. In a paper titled: “Magnetic Stimulation of the Blad
`der in Dogs’ presented at the 1993 AAEM Annual Meeting,
`the abstract of which was published in the Muscle & Nerve
`issue of October 1993, Lin et al. disclosed that magnetic
`stimulation could be employed to stimulate the cortex, spinal
`nerves and peripheral nerves of dogs through direct trans
`abdominal stimulation of the detrusor muscles or through
`stimulation of the lumbosacral roots.
`0017. As shown, the prior art makes no provision to mea
`sure the efficacy of PES treatment, causing patients to be
`treated improperly, either by an insufficient or excessive
`exposure to PES. Other attempts to monitor PES dosage in the
`prior art exhibit serious drawbacks. For example, U.S. Pat.
`No. 5.518,495 to Kot discloses an apparatus for the treatment
`of arthritis utilizing a magnetic field therapy, which includes
`an adjustable Voltage source that is connected to a source of
`line Voltage and a coil connected to the adjustable Voltage
`Source. This apparatus has no feedback system to advise a
`healthcare provider of the efficiency of the treatment.
`0018 U.S. Pat. No. 5,984.854 to Ishikawa et al. discloses
`a method for treating urinary incontinence based on deliver
`ing a train of current pulses through one or more magnetic
`stimulation coils so to induce a train of magnetic flux pulses,
`which then induce an eddy current within the body and stimu
`lates a group of pelvic floor muscles, the pudendal nerve, the
`external urethral sphincter, or the tibial nerve. While this
`method includes the use of pulsed electromagnetic for treat
`ing urinary incontinence, no specific components are envi
`Sioned to facilitate the placement of the magnetic coils over a
`targeted region of the body or a system for monitoring the
`efficiency of the therapy being applied.
`0019 U.S. Pat. No. 6,086,525 to Davey et al. discloses a
`magnetic nerve stimulator that includes a core constructed
`from a material having a high field Saturation having a coil
`winding disposed thereon. A thyrister capacitive discharge
`circuit pulses the device, and a rapidly changing magnetic
`field is guided by the core, preferably made from vanadium
`permendur.
`0020 U.S. Pat. No. 6,701,185 to Burnett et al. also dis
`closes an electromagnetic stimulation device that includes a
`plurality of overlapping coils, which can be independently
`energized in a predetermined sequence Such that each coil
`will generate its own independent electromagnetic field and
`significantly increase the adjacent field. Unfortunately, none
`of these patents provides a system for monitoring the effi
`ciency of the therapy in progress, either with respect to the
`
`proper positioning of the winding over the area to be treated
`or of the intensity of the magnetic field to be applied.
`0021. Other PES therapies require the implantation of
`devices into the patient, with the consequent discomfort, risk
`and cost to the patient. For example, U.S. Pat. No. 6,735,474
`to Loeb et al. discloses a method and system for treating UI
`and/or pelvic pain by injecting or laparoscopically implanting
`one or more battery- or radio frequency-powered microstimu
`lators that include electrodes placed beneath the skin of the
`perineum and/or adjacent the tibial nerve.
`0022 U.S. Pat. No. 6,941,171 to Mann et al. describes a
`method and a system for treating incontinence, urgency, fre
`quency, and/or pelvic pain that includes implantation of elec
`trodes on a lead or a discharge portion of a catheter adjacent
`the perineal nerves) or tissue(s) to be stimulated. Stimulation
`pulses, either electrical or drug infusion pulses, are Supplied
`by a stimulator implanted remotely through the lead or cath
`eter, which is tunneled subcutaneously between the stimula
`tor and stimulation site.
`(0023. Other PES therapies in the prior art involve the use
`of electrodes placedonor beneath the skin of a patient. Recent
`data on invasive, needle-based PES of the posterior tibial
`nerve in individuals with OAB and UI indicates that PES can
`modulate bladder dysfunction through its action on the
`pudendal nerve and the Sacral plexus, which provide the
`major excitatory input to the bladder.
`0024. In a paper titled “Percutaneous Tibial Nerve Stimu
`lation via Urgent R. PC Neuromodulation System. An
`Emerging Technology for managing Overactive Bladder.”
`which was published in Business Briefing: Global Surgery
`2004, CystoMedix, Inc. disclosed that peripheral tibial nerve
`stimulation (“PTNS) had been found effective in treating
`OAB. The disclosed procedure involved the use of electrode
`and generator components, including a small 34-gauge
`needle electrode, lead wires and a hand-held electrical gen
`erator. However, the procedure requires the permanent
`implantation of an electrical stimulation device in the patient.
`One estimate put the cost of treatment at nearly $14,000 with
`additional routine care costs of S593 per patient per year.
`Additionally, risks of battery failure, implant infection, and
`electrode migration led to a high re-operation rate and made
`this procedure unattractive.
`(0025 U.S. Pat. No. 7,117,034 to Kronberg discloses a
`method for generating an electrical signal for use in biomedi
`cal applications that includes two timing-interval generators.
`In this invention, skin-contact electrodes may be placed over
`an area of interestanda microprocessor may direct timing and
`sequencing functions, although Such timing and sequencing
`functions are not related to the actual efficacy of the treatment
`while treatment is being performed.
`(0026 U.S. Patent Application Publication No. 2005/
`0171576 to Williams et al. discloses an electro-nerve stimu
`lation apparatus that includes a pulse generator, a first elec
`trically conductive, insulated lead wire, a second electrically
`conductive, insulated lead wire, an electrically conductive
`transcutaneous electrode and an electrically conductive per
`cutaneous needle electrode. Connected to one end of the first
`and second lead wires is a connector for electrically coupling
`with the pulse generator. In this invention, a percutaneous
`needle electrode is inserted through the skin in proximity to
`the desired internal stimulation site and electric stimulation is
`employed, rather than pulsed electromagnetic stimulation.
`Moreover, the Williams invention does not contemplate
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`mechanisms for facilitating use of the device by an untrained
`user, nor a monitoring of the applied therapy.
`0027. A neuromodulation alternative is a posterior tibial
`nervestimulator, often referred to as SANS, but as is the case
`with other forms of neuromodulation, this procedure is inva
`sive in nature and requires the insertion of a needle five
`centimeters into the patient's ankle region to stimulate the
`posterior tibial nerve. This procedure also requires a mini
`mum of twelve sessions for initial treatment, possibly with
`additional sessions required for maintenance.
`0028. Also, therapies involving the use of traditional
`insertable or implantable percutaneous needles require pen
`etration into deepertissues and carry with them the added risk
`of infection, while causing pain and discomfort to the patient.
`This often results in ineffective treatment and or reduced
`patient compliance.
`
`SUMMARY
`0029. In certain embodiments, apparatus and methods for
`magnetic induction therapy, in which dosage of magnetic
`energy can be regulated according to conduction in a target
`nerve exposed to the magnetic field are provided.
`0030. In certain embodiments, apparatus and methods for
`magnetic induction therapy, in which the flow of magnetic
`energy can be adjusted directionally by the patient or a health
`care provider without altering the position of a housing con
`taining conductive coils that produce the magnetic field are
`provided.
`0031. In certain embodiments, apparatus and methods for
`treating a variety of ailments by providing energy to a target
`nerve, for example magnetic energy, electrical energy or
`ultrasound energy, at a location and in an amount optimized
`by detecting conduction in the target nerve are provided.
`0032. In certain embodiments, an energy emitting appara
`tus for delivering a medical therapy that includes one or more
`energy generators, a logic controller electrically connected to
`the one or more energy generators, and one or more sensors
`for detecting electric conduction in a target nerve, which are
`connected to the logic controller is provided. The one or more
`energy generators produce energy focused on the target nerve
`upon receiving a signal from the logic controller, and the
`applied energy is varied by the logic controller according to
`an input provided by the one or more sensors based on electric
`conduction in the target nerve. The feedback provided by the
`sensors to the logic controller about the efficacy of the applied
`treatment causes the logic controller to modulate the current
`transmitted to the coils.
`0033. The applied energy may be a magnetic field, an
`electrical field, an ultrasound, a visible light, or an infrared or
`an ultraviolet energy. When a magnetic field is applied, the
`energy-emitting device is an apparatus that provides a mag
`netic induction therapy and that includes one or more con
`ductive coils disposed in an ergonomic housing. A logic con
`troller is electrically connected to the one or more coils, and
`one or more sensors detect electric conduction in the target
`nerve and are connected to the logic controller so to provide
`a feedback to the logic controller. The conductive coils
`receive an electric current from the logic controller and pro
`duce a magnetic field focused on a target nerve, and the
`electric current fed by the logic controller is varied by the
`logic controller according to an input provided by the sensors,
`thereby causing amplitude, frequency or direction of the mag
`netic field, or the firing sequence of the one or more coils, to
`be varied according to the efficiency of the treatment provided
`
`to the target nerve. In certain embodiments, the housing con
`taining the conductive coils may be a flexible wrap, a cradle or
`a garment, and the coils may be overlapping and/or be dis
`posed in different positions within the housing, so to generate
`a magnetic field on different body parts with the desired
`direction and amplitude.
`0034. The one or more coils may be stationary or movable
`within the housing, making it possible to optimize the direc
`tion of magnetic flow to the target nerve by disposing the coils
`in the most effective direction. In different embodiments, the
`coils may be movable manually by acting on a knob, lever, or
`similar type of actuator, or may be translated automatically by
`the logic controller in response to the input provided by the
`sensors. When a preferred position for the coils has been
`established, the coils may be locked in position and maintain
`that position during Successive therapy sessions. In other
`embodiments, the sensors may be incorporated within the
`housing, or instead may be disposed on a body part of interest
`independently of the housing.
`0035. In still other embodiments, the inductive coils are
`disposed in a housing that is situated externally to a patient's
`body, and additional inductive coils are implanted into the
`body of the patient and are magnetically coupled to the exter
`nal inductive coils. With this coil arrangement, energy may be
`transmitted from the external coils to the internal coils either
`to recharge or to activate an implantable device. In yet other
`embodiments, the electric current may varied by the logic
`controller both on the basis of an input provided by the one or
`more sensors and also an input provided by the patient
`according to a muscular response she has perceived, for
`example, the twitching of a toe after application of the mag
`netic field.
`0036. In yet other embodiments, the source of energy for
`nervestimulation may be electrical energy and nerve conduc
`tion may be detected at a site sufficiently distant from the site
`of stimulation, so to enable detection of nerve conduction
`despite the confounding interference from the direct electri
`cal stimuli. In these embodiments, direct electrical stimula
`tion of nerve and muscle may be tailored to provide optimal
`therapy and, in the case of electrode migration or other elec
`trode malfunction, to report lack of stimulation of the bodily
`tissues. Furthermore, these embodiments enable a reduction
`in power requirement, because control of the signal is pro
`vided by the sensor to the signal generator loop.
`0037. In other embodiments, an energy emitting system
`for providing a medical therapy is provided. The system may
`include one or more conductive coils disposed within or along
`a housing and configured to generate a magnetic field focused
`on a target nerve in proximity to coils; one or more sensors in
`the form of microneedle patch configured to detect electrical
`conduction in the target nerve; and a controller coupled to the
`conductive coils and optionally in communication with the
`SSO.
`0038. In other embodiments, an energy emitting system
`for providing a medical therapy is provided. The system may
`include one or more microneedle patches having one or more
`microneedle arrays deposited on a Surface of one or more
`electrodes and configured to generate or deliver an electrical
`or magnetic stimulus or field focused on a target nerve in
`proximity to the microneedle patch; one or more sensors
`configured to detect electrical conduction in the target nerve;
`and a controller coupled to the conductive coils and option
`ally in communication with the sensor. Optionally, the above
`embodiments may incorporate an electrode needle. Option
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`US 2010/01 68501 A1
`
`Jul. 1, 2010
`
`ally, the above embodiments or systems may be utilized with
`out a sensor or mechanism for detecting conduction or stimu
`lation.
`0039 Methods of use of the above apparatus, systems and
`variations thereof for treating various conditions are also
`described herein.
`0040. Other features and advantages will appear hereinaf
`ter. The features and elements described herein can be used
`separately or together, or in various combinations of one or
`more of them.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0041. The drawings constitute a part of this specification
`and include exemplary embodiments of the invention, which
`may be embodied in various forms. It is to be understood that
`in Some instances various aspects of the embodiments may be
`shown exaggerated or enlarged to facilitate an understanding
`of the embodiments.
`0042 FIG. 1 is a schematic view of an apparatus for mag
`netic induction therapy according to a first embodiment of the
`invention.
`0043 FIG. 2 is a schematic view of an apparatus for mag
`netic induction therapy according to a second embodiment of
`the invention.
`0044 FIG. 3 is a schematic view of an apparatus for mag
`netic induction therapy according to a third embodiment of
`the invention.
`0045 FIG. 4 is a schematic view of an apparatus for mag
`netic induction therapy according to a fourth embodiment of
`the invention.
`0046 FIG. 5 is a schematic view of an apparatus for mag
`netic induction therapy according to a fifth embodiment of the
`invention.
`0047 FIGS. 6A-6D are schematic illustrations depicting a
`first method of use of an apparatus for magnetic induction
`therapy. This method is based on adjusting the position of the
`conductive coils so to optimize a magnetic flow applied to a
`target nerve.
`0048 FIGS. 7A-7D are schematic illustrations of a second
`methodofuse of an apparatus for magnetic induction therapy.
`This method is based on locking the conductive coils in
`position once electrical conduction in a target nerve has been
`detected.
`0049 FIG. 8 is a schematic view of an embodiment of the
`invention that includes a plurality of sensors.
`0050 FIGS. 9A-9D are schematic representations of dif
`ferent garments adapted to operate as apparatus for magnetic
`induction therapy according to the principles of the present
`invention.
`0051
`FIG. 10 is a schematic view of an apparatus for
`providing electrical stimulation.
`0.052
`FIG. 11 is a schematic view of another embodiment
`of an apparatus for providing electrical stimulation.
`0053 FIG. 12 shows a schematic view of an energy emit
`ting system including a microneedle patch sensor.
`0054 FIG. 13-15 shows magnified bottom views of vari
`ous embodiments of microneedle patches.
`0055 FIGS. 16-17 shows magnified side views of various
`embodiments of a microneedle patch.
`0056 FIG. 18 shows a magnified bottom perspective view
`of a microneedle patch.
`0057 FIG. 19 shows a representative cross sectional view
`of the skin composed of an outer stratum corneum covering
`
`the epidermal and dermal layers of skin and the underlying
`Subcutaneous tissue, with a variation of a microneedle patch
`attached thereto.
`0.058
`FIG. 20 shows a magnified side view of a variation
`of a microneedle patch including multiple electrodes.
`0059 FIG. 21 shows a schematic view of an energy emit
`ting system including a microneedle patch sensor placed
`behind a subject's knee.
`0060 FIGS. 22-23 show schematic views of energy emit
`ting systems including an electrode needle and sensor.
`0061
`FIGS. 24-25 show schematic views of energy emit
`ting systems including an electrode needle without a sensor.
`0062 FIG. 26 shows a schematic view of an energy emit
`ting system including a microneedle patch for providing
`stimulation.
`0063 FIGS. 27-28 show schematic views of energy emit
`ting systems including an electrode needle and microneedle
`patch for providing stimulation.
`0064 FIG. 29a-29d show a prospective, side, top and rear
`views of an energy emitting device in the form of a foot
`cradle.
`0065 FIGS. 30-31 show schematic views of an energy
`emitting device in the form of a knee cradle.
`
`DETAILED DESCRIPTION OF EMBODIMENTS
`OF THE INVENTION
`Detailed descriptions of embodiments of the inven
`0.066
`tion are provided herein. It is to be understood, however, that
`the present invention may be embodied in various forms.
`Therefore, the specific details disclosed herein are not to be
`interpreted as limiting, but rather as a representative basis for
`teaching one skilled in the art how to employ the present
`invention in virtually any detailed system, structure, or man
`.
`0067 Various embodiments of the invention will now be
`described. The following description provides specific details
`for a thorough understanding and enabling, description of
`these embodiments. One skilled in the art will understand,
`however, that the embodiments may be practiced without
`many of these details. Additionally, Some well-known struc
`tures or functions may not be shown or described in detailso
`as to avoid unnecessarily obscuring the relevant description
`of the various embodiments.
`0068. The terminology used in the description presented
`below is intended to be interpreted in its broadest reasonable
`manner, even though it is being used in conjunction with a
`detailed description of certain specific embodiments of the
`invention. Certain terms may even be emphasized below. Any
`terminology intended to be interpreted in any restricted man
`ner, however, will be overtly and specifically defined as such
`in this detailed description section.
`0069. Where the context permits, singular or plural terms
`may also include the plural or singular term, respectively.
`Moreover, unless the word 'or' is expressly limited to mean
`only a single item exclusive from the other items in a list of
`two or more items, then the use of 'or' in such a list